Recruiting NCT07041099

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease

Phase I Interventional Sjögren Sjogren Disease Sjogren's Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: CLN-978.
Who it may be relevant to: Registry conditions: Sjögren, Sjogren Disease, Sjogren's Syndrome. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, France, Germany, Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Secondary outcome measures (3)

To evaluate the PK of CLN-978 [Time frame: 48 weeks]
Detection of anti-drug antibodies [Time frame: 48 weeks]
Change from baseline in B lymphocyte cell numbers in peripheral blood [Time frame: 48 weeks]

Inclusion

Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening.
Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.
Laboratory parameters including the following:

Absolute lymphocyte count (ALC) ≥0.5 × 10\^9/L
Peripheral CD19+ B cell count ≥25 cells/µL
Absolute neutrophil count (ANC) ≥1.0 × 10\^9/L
Hemoglobin (Hgb) ≥8 g/dL
Platelet count ≥75 × 10\^9/L
Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN
Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL/min/1.73 m2

Exclusion

Concomitant rheumatological autoimmune disease
Considered at high risk for thrombosis
Rapidly progressive glomerulonephritis and/or urine protein/creatinine >3 mg/mg (339 mg/mmol).
Active, severe central nervous system manifestations of SjD.
History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results.
Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
Primary immunodeficiency or history of recurrent infections.
History of splenectomy.
Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period.
Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1.
Active or latent tuberculosis (TB)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 5 centers

France · 3 centers

Germany · 2 centers

Italy · 1 center

NCT: NCT07041099 · CLN-978-SJ-101